A Phase 1, Exploratory, Randomized, Double-Blind, Two-Way Cross Over Study to Assess Pharmacokinetic and Pharmacodynamic Effects of Gan & Lee's Insulin Glargine Injection in Comparison to Lantus in Subjects With Type 1 Diabetes Mellitus

Trial Profile

A Phase 1, Exploratory, Randomized, Double-Blind, Two-Way Cross Over Study to Assess Pharmacokinetic and Pharmacodynamic Effects of Gan & Lee's Insulin Glargine Injection in Comparison to Lantus in Subjects With Type 1 Diabetes Mellitus

Completed
Phase of Trial: Phase I

Latest Information Update: 02 Feb 2017

At a glance

  • Drugs Insulin glargine (Primary)
  • Indications Type 1 diabetes mellitus
  • Focus Pharmacodynamics; Pharmacokinetics
  • Sponsors Gan&Lee Pharmaceuticals
  • Most Recent Events

    • 25 Jan 2017 Status changed from recruiting to completed.
    • 08 Aug 2016 Planned End Date changed from 1 Jul 2016 to 1 Sep 2016.
    • 08 Aug 2016 Planned primary completion date changed from 1 Jun 2016 to 1 Aug 2016.
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